510(k) K862635
K862635 is an FDA 510(k) premarket notification submitted by Arnell, Inc. for the device "RABINOWITZ GUM MASSAGER". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code JEW (Tip, Rubber, Oral Hygiene), a Class I device regulated under 21 CFR 872.6650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1986
- Date Received
- July 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tip, Rubber, Oral Hygiene
- Device Class
- Class I
- Regulation Number
- 872.6650
- Review Panel
- DE
- Submission Type